Replacement mitral valves

ABSTRACT

A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of International PatentApplication No. PCT/US2018/14902, filed Jan. 23, 2018, titled“REPLACEMENT MITRAL VALVES”, which claims priority to U.S. ProvisionalApplication No. 62/513,877, filed Jun. 1, 2017 and to U.S. ProvisionalPatent Application No. 62/449,498, filed Jan. 23, 2017, and titled“REPLACEMENT MITRAL VALVES,” the entireties of which are incorporated byreference herein.

This application may also be related to International Patent ApplicationNo. PCT/US2016/032550, filed May 13, 2016, titled “REPLACEMENT MITRALVALVES”, to U.S. patent application Ser. No. 14/170,388, filed Jan. 31,2014, titled “SYSTEM AND METHOD FOR CARDIAC VALVE REPAIR ANDREPLACEMENT,” now U.S. Pat. No. 8,870,948, and to U.S. patentapplication Ser. No. 14/677,320, filed Apr. 2, 2015, titled “REPLACEMENTCARDIAC VALVES AND METHODS OF USE AND MANUFACTURE,” the entireties ofwhich are incorporated by reference herein.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND

The mitral valve lies between the left atrium and the left ventricle ofthe heart. Various diseases can affect the function of the mitral valve,including degenerative mitral valve disease and mitral valve prolapse.These diseases can cause mitral stenosis, in which the valve fails toopen fully and thereby obstructs blood flow, and/or mitralinsufficiency, in which the mitral valve is incompetent and blood flowspassively in the wrong direction.

Many patients with heart disease, including those with mitral valveproblems, are intolerant of the trauma associated with open-heartsurgery. Age or advanced illness may have impaired the patient's abilityto recover from the injury of an open-heart procedure. Additionally, thehigh costs associated with open-heart surgery and extra-corporealperfusion can make such procedures prohibitive.

Patients in need of cardiac valve repair or cardiac valve replacementcan be served by minimally invasive surgical techniques. In manyminimally invasive procedures, small devices are manipulated within thepatient's body under visualization from a live imaging source likeultrasound, fluoroscopy, or endoscopy. Minimally invasive cardiacprocedures are inherently less traumatic than open procedures and may beperformed without extra-corporeal perfusion, which carries a significantrisk of procedural complications.

Minimally invasive aortic valve replacement devices, such as theMedtronic Corevalve or the Edwards Sapien, deliver aortic valveprostheses through small tubes which may be positioned within the heartthrough the aorta via the femoral artery or through the apex of theheart. However, the mitral valve differs from the aortic valve in thatthe shape and anatomy immediately surrounding the valve varies greatlyfrom one side of the valve to the other. Moreover, current cardiac valveprostheses are not designed to function effectively within the mitralvalve. Further, current cardiac valve prostheses delivered via aminimally invasive device are often difficult to place correctly withinthe native valve, difficult to match in size to the native valve, anddifficult to retrieve and replace if initially placed incorrectly.

These and other deficiencies in existing approaches are describedherein.

SUMMARY OF THE DISCLOSURE

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly, a strut frame, and a plurality of replacement leafletssecured to the annular strut frame. The anchor assembly includes aventricular anchor, an atrial anchor, and a central portiontherebetween. The ventricular anchor and the atrial anchor areconfigured to flare radially outwards relative to the central portion.The annular strut frame is disposed radially within the anchor assemblyand is attached to the anchor assembly at a plurality of attachmentlocations that are positioned between the central portion and anatrial-most edge of the anchor assembly. The central portion isconfigured to align with a native valve orifice and the ventricularanchor and the atrial anchor are configured to compress native cardiactissue therebetween.

This and other embodiments can include one or more of the followingfeatures. An atrial end of the strut frame can be attached to the anchorassembly. Atrial tips of the strut frame can be attached to the anchorassembly. An atrial end of the strut frame can be flared radiallyoutwards. A flare of the strut frame can be configured to substantiallyconform to a flare of the atrial anchor. A ventricular end of the strutframe can be spaced away from the anchor assembly. The ventricular endof the strut frame can be spaced away from the anchor assembly by aradial distance of 1-15 mm. The anchor assembly and the strut frame canbe configured to self-expand from a constrained configuration to anexpanded configuration. The strut frame can be attached to the anchorassembly with a plurality of rivets. Each of the plurality of attachmentlocations can be radially aligned with tips of the atrial anchor. Theplurality of attachment locations can each be part of the anchorassembly that extends further radially inwards than a remaining portionof the anchor assembly. The anchor assembly can comprise a plurality ofdiamond-shaped cells. The plurality of attachment locations can bepositioned at a mid-point of the outermost atrial diamond-shaped cells.The strut frame can include a plurality of linear struts and v-shapedconnectors therebetween. The anchor assembly can form a substantiallyhour-glass shape.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly, an annular strut frame, and a plurality of replacementleaflets secured to the annular strut frame. The anchor assemblyincludes a ventricular anchor, an atrial anchor, and a central portiontherebetween. The ventricular anchor and the atrial anchor areconfigured to flare radially outwards relative to the central portion.Further, the anchor assembly comprises a plurality of diamond-shapedcells. The annular strut frame is disposed radially within the anchorassembly and is attached to the anchor assembly at a plurality ofattachment locations that are positioned at a mid-point of the outermostatrial diamond-shaped cells between the central portion and anatrial-most edge of the anchor assembly.

This and other embodiments can include one or more of the followingfeatures. An atrial end of the strut frame can be attached to the anchorassembly. Atrial tips of the strut frame can be attached to the anchorassembly. An atrial end of the strut frame can be flared radiallyoutwards. A flare of the strut frame can be configured to substantiallyconform to a flare of the atrial anchor. A ventricular end of the strutframe can be spaced away from the anchor assembly. The ventricular endof the strut frame can be spaced away from the anchor assembly by aradial distance of 1-15 mm. The anchor assembly and the strut frame canbe configured to self-expand from a constrained configuration to anexpanded configuration. The strut frame can be attached to the anchorassembly with a plurality of rivets. Each of the plurality of attachmentlocations can be radially aligned with tips of the atrial anchor. Theplurality of attachment locations can each be part of the anchorassembly that extends further radially inwards than a remaining portionof the anchor assembly. The strut frame can include a plurality oflinear struts and v-shaped connectors therebetween. The anchor assemblycan form a substantially hour-glass shape.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly, an annular strut frame, and a plurality of replacementleaflets secured to the annular strut frame. The anchor assembly furtherincludes a ventricular anchor, an atrial anchor, and a central portiontherebetween. The ventricular anchor and the atrial anchor areconfigured to flare radially outwards relative to the central portion.Further, the atrial anchor includes a plurality of atrial cells and theventricular anchor includes a plurality of ventricular cells. Theannular strut frame is disposed radially within the anchor assembly. Afirst plurality of the atrial cells are positioned radially inwardsrelative to a second plurality of the atrial cells such that the firstplurality of cells attach the strut frame to the anchor assembly.

This and other embodiments can include one or more of the followingfeatures. The central portion can be configured to align with a nativevalve orifice, and the ventricular anchor and the atrial anchor can beconfigured to compress native cardiac tissue therebetween. An atrial endof the strut frame can be attached to the anchor assembly. Atrial tipsof the strut frame can be attached to the anchor assembly. An atrial endof the strut frame can be flared radially outwards. A flare of the strutframe can be configured to substantially conform to a flare of theatrial anchor. A ventricular end of the strut frame can be spaced awayfrom the anchor assembly. The ventricular end of the strut frame can bespaced away from the anchor assembly by a radial distance of 1-15 mm.The anchor assembly and the strut frame can be configured to self-expandfrom a constrained configuration to an expanded configuration. The strutframe can be attached to the anchor assembly with a plurality of rivets.The first plurality of atrial cells can end in disconnected apexes. Thedisconnected apexes can be radially aligned with outer-most tips of thesecond plurality of atrial cells. The first plurality of atrial cellscan be angled at approximately 70-80 degrees relative to the axis thatextends through the central portion. The second plurality of atrialcells can be angled at approximately 20-30 degrees relative to the axisthat extends through the central portion. The annular strut frame canflare radially outwards at 70-80 degrees relative to the axis thatextends through the central portion.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly, an annular strut frame, and a plurality of replacementleaflets secured to the annular strut frame. The anchor assemblyincludes a ventricular anchor, an atrial anchor, and a central portiontherebetween. The ventricular anchor and the atrial anchor areconfigured to flare radially outwards relative to the central portion.Further, the atrial anchor includes a plurality of atrial cells. Theannular strut frame is disposed radially within the anchor assembly. Afirst plurality of the atrial cells are interior disconnected apexes andthe second plurality of atrial cells are outermost atrial cells. Thefirst plurality positioned radially inwards relative to a secondplurality of the atrial cells such that the first plurality of cellsattach the strut frame to the anchor assembly.

This and other embodiments can include one or more of the followingfeatures. The central portion can be configured to align with a nativevalve orifice. The ventricular anchor and the atrial anchor can beconfigured to compress native cardiac tissue therebetween. An atrial endof the strut frame can be attached to the anchor assembly. Atrial tipsof the strut frame can be attached to the anchor assembly. An atrial endof the strut frame can be flared radially outwards. A flare of the strutframe can be configured to substantially conform to a flare of theatrial anchor. A ventricular end of the strut frame can be spaced awayfrom the anchor assembly. The ventricular end of the strut frame can bespaced away from the anchor assembly by a radial distance of 1-15 mm.The anchor assembly and the strut frame can be configured to self-expandfrom a constrained configuration to an expanded configuration. The strutframe can be attached to the anchor assembly with a plurality of rivets.The disconnected apexes can be radially aligned with outer-most tips ofthe second plurality of atrial cells. The first plurality of atrialcells can be angled at approximately 70-80 degrees relative to an axisthat extends through the central portion. The second plurality of atrialcells can be angled at approximately 20-30 degrees relative to the axisthat extends through the central portion. The annular strut frame canflare radially outwards at 70-80 degrees relative to the axis thatextends through the central portion.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly that includes a ventricular anchor and an atrialanchor. The valve support assembly has a plurality of slotstherethrough. The prosthetic mitral valve further includes a pluralityof replacement leaflets. Each leaflet has a leaflet arm extendingthrough one of the plurality of slots. The prosthetic mitral valvefurther includes a plurality of commis sure plates. Each commis sureplate is circumferentially and axially aligned with one of the pluralityof slots to form a commis sure attachment mechanism. Each commissureplate further includes a plurality of channels in the sides thereof. Theat least one suture is positioned at each commissure attachmentmechanism and is wrapped around a portion of the valve support assembly,through the plurality of indents, and around the commissure plate.

This and other embodiments can include one or more of the followingfeatures. The valve support assembly can include an anchor assembly thatincludes the ventricular and atrial anchors and an annular strut framethat includes the plurality of slots. The annular strut frame can bepositioned radially within the anchor assembly. The plurality of slotscan be in a portion of the strut frame that extends past the anchorassembly in the ventricular direction. The anchor assembly can furtherinclude a central portion, and the ventricular and atrial anchors canflare radially outwards relative to the central portion. The pluralityof channels can extend from the sides of each commissure plate towards acenter of the plate. The plurality of channels can be substantiallystraight. There can be between 6 and 12 channels in each commis sureplate. Each of the slots can be in an axially extending strut. Arms ofthe leaflets can extend through the plurality of slots. The arms can befurther be wound around an outer perimeter of an inner strut frame ofthe valve support assembly. The plurality of slots can be positionedequidistance around a circumference of the valve support assembly. Eachof the plurality of slots can be positioned towards a ventricular end ofthe valve support assembly. The valve support assembly can be configuredto self-expand from a constrained configuration to an expandedconfiguration. Atrial edges of the leaflets can be sewn around an innercircumference of the valve support assembly. Each of the leafletsfurther includes a leaflet protector thereon. The leaflet protector canbe made of a lubricious fabric and can be configured to protect therespective leaflet from an inner circumference of the valve supportassembly.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly. The valve support assembly includes an anchorassembly having a ventricular anchor and an atrial anchor and an annularstrut frame positioned radially within the anchor assembly. The annularstrut frame includes a plurality of slots therethrough. The prostheticmitral valve further includes a plurality of replacement leaflets. Eachleaflet has a leaflet arm extending through one of the plurality ofslots. The prosthetic mitral valve further includes a plurality ofcommissure plates. Each commissure plate is circumferentially andaxially aligned with one of the plurality of slots to form a commissureattachment mechanism. Each commissure plate further includes a pluralityof channels in the sides thereof.

This and other embodiments can include one or more of the followingfeatures. The prosthetic mitral valve can include at least one suture ateach commissure attachment mechanism. The at least one suture can bepositioned around the strut frame, through the plurality of indents, andaround the commis sure plate. The plurality of slots can be in a portionof the strut frame that extends past the anchor assembly in theventricular direction. The anchor assembly can further include a centralportion, and the ventricular and atrial anchors can be flared radiallyoutwards relative to the central portion. The plurality of channels canextend from the sides of each commissure plate towards a center of theplate. The plurality of channels can be substantially straight. Therecan be between 6 and 12 channels in each commis sure plate. Each of theslots can be in an axially extending strut. The arms of the leaflets canextend through the plurality of slots. The arms can be further be woundaround an outer perimeter of the strut frame. The plurality of slots canbe positioned equidistance around a circumference of the strut frame.Each of the plurality of slots can be positioned towards a ventricularend of the strut frame. The valve support assembly can be configured toself-expand from a constrained configuration to an expandedconfiguration. Atrial edges of the leaflets can be sewn around an innercircumference of the strut frame. Each of the leaflets can furtherinclude a leaflet protector thereon. The leaflet protector can be madeof a lubricious fabric and can be configured to protect the leaflet froman inner circumference of the valve support assembly.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly, a plurality of leaflets secured to the valvesupport assembly, and a plurality of retention hooks. The valve supportassembly includes a ventricular anchor, a central portion, and an atrialanchor. The valve support assembly is configured to self-expand from acollapsed configuration to an expanded configuration. The plurality ofretention hooks are attached to the ventricular anchor. Each of theretention hooks curves radially outwards to point in an atrial directionwhen the valve support assembly is in the expanded configuration. Eachretention hook has a ratio of radius of curvature to thickness ofgreater than 4:1.

This and other embodiments can include one or more of the followingfeatures. Each of the plurality of retention hooks can be configured topoint at an angle of 50°-80° relative to a central longitudinal axis ofthe prosthetic mitral valve. The angle can be approximately 65°. Aradius of curvature of each of the plurality of retention hooks can bebetween 3-5 mm. A thickness of each retention hooks can be between 0.8mm and 1.6 mm. The plurality of retention hooks can be integral with thevalve support assembly. The valve support assembly can include an anchorassembly that further includes the ventricular and atrial anchors andthe central portion and an annular strut frame positioned radiallywithin the anchor assembly. The plurality of retention hooks can beattached to the anchor assembly. The central portion can be configuredto align with a native valve orifice, and the ventricular anchor and theatrial anchors can be configured to compress native cardiac tissuetherebetween. The valve support assembly can include a plurality ofdiamond-shaped cells. Each of the retention hooks can extend from anapex of an interior diamond-shaped cell. A retention hook can extendfrom each apex in a circumferential line around the prosthetic mitralvalve except at positions closest to leaflet attachment points.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly, a plurality of leaflets secured to the valvesupport assembly, and a plurality of retention hooks. The valve supportassembly includes a ventricular anchor, a central portion, and an atrialanchor. Each of the retention hooks is attached to the ventricularanchor and curves radially outwards to point in an atrial direction.Each retention hook has a ratio of radius of curvature to thickness ofgreater than 4:1 and points at an angle of 10°-40° relative to a centrallongitudinal axis of the prosthetic mitral valve.

This and other embodiments can include one or more of the followingfeatures. The angle can be approximately 65°. A radius of curvature ofeach of the plurality of retention hooks can be between 3-5 mm. Athickness of each retention hooks can be between 0.8 mm and 1.6 mm. Theplurality of retention hooks can be integral with the valve supportassembly. The valve support assembly can include an anchor assembly thatfurther includes the ventricular and atrial anchors and the centralportion and an annular strut frame positioned radially within the anchorassembly. The plurality of retention hooks can be attached to the anchorassembly. The central portion can be configured to align with a nativevalve orifice, and the ventricular anchor and the atrial anchors can beconfigured to compress native cardiac tissue therebetween. The valvesupport assembly can include a plurality of diamond-shaped cells. Eachof the retention hooks can extend from an apex of an interiordiamond-shaped cell. A retention hook can extend from each apex in acircumferential line around the prosthetic mitral valve except atpositions closest to leaflet attachment points.

In general, in one embodiment, a replacement mitral valve includes aself-expandable valve support assembly that includes a ventricularanchor, a central portion, and an atrial anchor. The valve supportassembly has a self-expanded configuration in which the ventricularanchor and the atrial anchor are flared radially outward relative to thecentral portion. The atrial anchor has a larger diameter than theventricular anchor when the valve assembly is in the self-expandedconfiguration. The replacement mitral valve further includes a pluralityof replacement leaflets secured to the valve assembly.

This and other embodiments can include one or more of the followingfeatures. The ventricular anchor can have outer diameter of less than 55mm. The atrial anchor can have diameter that is 3-10% larger thandiameter of ventricular anchor. The valve support assembly can includean anchor assembly that includes the central portion and ventricular andatrial anchors. The valve support assembly can further include anannular strut frame positioned radially within the anchor assembly. Theanchor assembly can be made of a plurality of diamond-shaped cellsjoined together. The valve support assembly can be configured toself-expand from a constrained configuration to an expandedconfiguration. The anchor assembly can be configured to foreshorten whentransitioning from the constrained configuration to the expandedconfiguration. The anchor assembly can be configured to take on anhour-glass shape. Tips of the atrial anchor can point in a ventriculardirection. The atrial and ventricular anchors can be configured tocompress native cardiac tissue therebetween. The atrial anchor caninclude a plurality of atrial tips and the ventricular anchor caninclude a plurality of ventricular tips. There can be more ventriculartips than atrial tips.

In general, in one embodiment, a replacement mitral valve includes avalve support assembly that includes a ventricular anchor, a centralportion, and an atrial anchor. The valve support assembly has aself-expanded configuration in which the ventricular anchor and theatrial anchor are flared radially outward relative to the centralportion. The atrial anchor has a diameter that is 3-10% larger than adiameter of the ventricular anchor. The replacement mitral valve furtherincludes a plurality of replacement leaflets secured to the valveassembly.

This and other embodiments can include one or more of the followingfeatures. The ventricular anchor can have outer diameter of less than 55mm. The valve support assembly can include an anchor assembly includingthe central portion and ventricular and atrial anchors. The valvesupport assembly can further include an annular strut frame positionedradially within the anchor assembly. The anchor assembly can be made ofa plurality of diamond-shaped cells joined together. The valve supportassembly can be configured to self-expand from a constrainedconfiguration to an expanded configuration. The anchor assembly can beconfigured to foreshorten when transitioning from the constrainedconfiguration to the expanded configuration. The anchor assembly can beconfigured to take on an hour-glass shape. Tips of the atrial anchor canpoint in a ventricular direction. The atrial and ventricular anchors canbe configured to compress native cardiac tissue therebetween. The atrialanchor can include a plurality of atrial tips and the ventricular anchorcan include a plurality of ventricular tips. There can be moreventricular tips than atrial tips.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly that includes a ventricular anchor, an atrial anchor,and a central portion therebetween. The anchor assembly is configured tocompress native cardiac tissue between the ventricular anchor and theatrial anchor. An annular strut frame is disposed radially within theanchor assembly and attached thereto. The prosthetic mitral valvefurther includes a plurality of replacement leaflets secured to theannular strut frame. The anchor assembly and annular strut frame areconfigured to self expand from a collapsed configuration to an expandedconfiguration. The anchor assembly is configured to foreshorten along acentral axis of the prosthetic mitral valve when expanding from thecollapsed configuration to the expanded configuration. The annular strutframe is configured to be substantially nonforeshortening along thecentral axis when expanding from the collapsed configuration to theexpanded configuration.

This and other embodiments can include one or more of the followingfeatures. The anchor assembly can include a plurality of diamond-shapedcells. The ventricular anchor can include a plurality of struts andv-shaped connecting members. The ventricular anchor and atrial anchorscan flare radially outwards relative to the central portion when in theexpanded configuration. The anchor assembly can be configured toforeshorten by 20-30% when self-expanding from the collapsedconfiguration to the expanded configuration.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly that includes a ventricular anchor, an atrial anchor,and a central portion therebetween. The anchor assembly is configured tocompress native cardiac tissue between the ventricular anchor and theatrial anchor. An annular strut frame is disposed radially within theanchor assembly such that the annular strut frame is spaced radiallyaway from the central portion of the anchor assembly. The prostheticmitral valve further includes a plurality of replacement leafletssecured to the annular strut frame.

This and other embodiments can include one or more of the followingfeatures. The annular strut frame can be spaced radially away from thecentral portion by 2-3 mm. The annular strut frame can be flared at anatrial end. Atrial tips of the annular strut frame can be attached tothe anchor assembly. A portion of the anchor assembly can be pulledradially inwards relative to a remainder of the anchor assembly so as toattach to the annular strut frame.

In general, in one embodiment, a prosthetic mitral valve includes avalve assembly that includes a ventricular anchor, a central portion,and an atrial anchor. The anchor assembly is configured to expand from acollapsed configuration to an expanded configuration. The atrial anchorincludes a plurality of atrial cells forming peaks and valleys around acircumference thereof, and the ventricular anchor includes a pluralityof ventricular cells forming peaks and valleys around a circumferencethereof. A plurality of replacement leaflets are secured to the valveassembly. A plurality of retention hooks are attached only to theventricular anchor. Each of the plurality of retention hooks ispositioned in a valley between the ventricular cells when the valveassembly is in the expanded configuration.

This and other embodiments can include one or more of the followingfeatures. The plurality of retention hooks can curve to point in theatrial direction when the anchor assembly is in the expandedconfiguration. The valve assembly can be configured to self-expand. Theplurality of retention hooks can point at an angle of 50°-80° relativeto a horizontal axis of the prosthetic mitral valve. The plurality ofretention hooks can be positioned in every valley except valleys closestto leaflet attachment points.

In general, in one embodiment, a prosthetic mitral valve includes ananchor assembly that includes a ventricular anchor, a central portion,and an atrial anchor. The anchor assembly configured to expand from acollapsed configuration to an expanded configuration. The atrial anchorincludes a plurality of atrial cells at an atrial edge of the atrialanchor, and the ventricular anchor includes a plurality of ventricularcells at a ventricular edge of the ventricular anchor. The number ofventricular cells is divisible by 2, and the number of atrial cells isdivisible by 3. An annular strut frame is positioned within the anchorassembly and includes a plurality of struts connected by connectionmembers. Three of the struts include commis sure attachment points. Thethree commissure attachment points are spaced equally around acircumference of the annular strut frame. Three replacement leaflets aresecured to the annular strut frame at the commissure attachment points.

This and other embodiments can include one or more of the followingfeatures. There can be 30 ventricular cells, 15 atrial cells, and 15struts. There can be 24 ventricular cells, 12 atrial cells, and 12struts. There can be more ventricular cells than atrial cells. Thenumber of ventricular cells can also be divisible by 3.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly, a plurality of leaflets, and a plurality ofretention hooks. The valve support assembly includes a ventricularanchor, a central portion, and an atrial anchor. The valve supportassembly is configured to self-expand from a collapsed configuration toan expanded configuration. The plurality of leaflets are secured to thevalve support assembly, and the plurality of retention hooks areattached to the ventricular anchor. Each of the retention hooks curvesradially outwards to point in an atrial direction when the valve supportassembly is in the expanded configuration, and each retention hook has aratio of radius of curvature to thickness of 4:1 or greater.

This and other embodiments can include one or more of the followingfeatures. The ratio can be between 4:1 and 8:1. Each of the plurality ofretention hooks can be configured to point at an angle of 10-40 degreesrelative to a central longitudinal axis of the prosthetic mitral valve.The angle can be approximately 28°. A radius of curvature of each of theplurality of retention hooks can be less than 4 mm. A radius ofcurvature of each of the plurality of retention hooks can be between 2mm-mm. A thickness of each of the plurality of retention hooks can beless than 1.6 mm. A thickness of each retention hooks can be between0.25 mm and 1 mm. A ratio of width to thickness of each retention hookcan be between 0.3:1 and 1:1. Each hook can be configured to engageapproximately 3-10 mm of mitral valve tissue when the valve supportassembly is in the expanded configuration. The plurality of retentionhooks can be integral with the valve support assembly. The valve supportassembly can include an anchor assembly including the ventricular andatrial anchors and the central portion and an annular strut framepositioned radially within the anchor assembly. The plurality ofretention hooks can be attached to the anchor assembly. The centralportion can be configured to align with a native valve orifice, and theventricular anchor and the atrial anchors can be configured to compressnative cardiac tissue therebetween. The valve support assembly caninclude a plurality of diamond-shaped cells, and each of the retentionhooks can extend from an apex of an interior diamond-shaped cell. Aretention hook can extend from each apex in a circumferential linearound the prosthetic mitral valve except a position closest to aleaflet attachment point.

In general, in one embodiment, a prosthetic mitral valve includes avalve support assembly, a plurality of leaflets, and a plurality ofretention hooks. The valve support includes a ventricular anchor, acentral portion, and an atrial anchor. The plurality of leaflets aresecured to the valve support assembly, and the plurality of retentionhooks are attached to the ventricular anchor. Each of the retentionhooks curves radially outwards to point in an atrial direction, and eachretention hook has a ratio of radius of curvature to thickness ofgreater than 4:1 and points at an angle of 10°-40° relative to a centrallongitudinal axis of the prosthetic mitral valve.

This and other embodiments can include one or more of the followingfeatures. A ratio of width to thickness of each retention hook can bebetween 0.3:1 and 1:1. Each hook can be configured to engageapproximately 3-10 mm of mitral valve tissue when the valve supportassembly is in the expanded configuration. A radius of curvature of eachof the plurality of retention hooks can be less than 4 mm.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1C show an exemplary mitral valve prosthesis. FIGS. 1A-1B showthe mitral valve prosthesis in an expanded configuration. FIG. 1C showsa portion of the expanded anchor assembly in 2D.

FIGS. 2A-2E show another exemplary mitral valve prosthesis. FIGS. 2A-2Bshow the mitral valve prosthesis in an expanded configuration. FIG. 2Cshows a portion of the expanded anchor assembly in 2D. FIG. 2D shows theexpanded annular strut frame. FIG. 2E shows a 2D pattern (pre-expanded)for the strut frame.

FIG. 3A-3C show another exemplary mitral valve prosthesis. FIGS. 3A-3Bshow the mitral valve prosthesis in an expanded configuration. FIG. 3Cshows the expanded annular strut frame.

FIGS. 4A-4C show another exemplary mitral valve prosthesis in anexpanded configuration.

FIGS. 5A-5C show an exemplary nonforeshortening anchor assembly in theexpanded configuration.

FIGS. 6A-6C show another exemplary nonforeshortening anchor assembly inthe expanded configuration.

FIGS. 7A-7B show an exemplary anchor assembly before it is heat-set intoan hour-glass shape.

FIGS. 8A-8G show another exemplary mitral valve prosthesis. FIGS. 8A-8Cshow the mitral valve prosthesis in the expanded configuration. FIGS.8D-8E show the expanded anchor assembly. FIG. 8F shows a portion of theexpanded anchor assembly in 2D. FIG. 8G shows a 2D pattern(pre-expanded) for the anchor assembly.

FIGS. 9A-9D show another exemplary nonforeshortening anchor assembly.FIGS. 9A-9C show the anchor assembly in the expanded configuration. FIG.9D shows a 2D pattern (pre-expanded) for the anchor assembly.

FIG. 10 shows an exemplary valve assembly including the anchor assembly,strut frame, skirt, and leaflets.

FIGS. 11A-11E show one exemplary mechanism of attaching leaflets to thestrut frame. FIG. 11A shows an exemplary commissure plate. FIG. 11Bshows a cross-sectional view of leaflets extending between the twocommissure plates. FIG. 11C shows a valve assembly having a strut with aseries of holes therein for attachment of leaflets to the valveassembly. FIG. 11D shows a cross-sectional view of the leaflets andcommissure plates attached to the strut. FIG. 1E shows a close-up of aportion of the strut with holes therein.

FIG. 12 shows another exemplary mechanism of attaching leaflets to thestrut frame.

FIGS. 13A-13B show deployment of a ventricular anchor of an exemplarymitral valve prosthesis out of a sheath.

FIG. 14 is a cross-section showing another exemplary mechanism ofattaching leaflets.

FIG. 15A-15C show another exemplary mechanism of attaching leaflets.FIG. 15A shows a secondary member including a slot. FIG. 15B is across-sectional view showing the leaflets passed through the slot of thesecondary member and around a strut of the strut frame. FIG. 15C showsalignment of the secondary member and the strut.

FIGS. 16A-16D show a holder including an exemplary mitral valveprosthesis with a skirt or covering.

FIGS. 17A-17J show an exemplary method of deploying a valve prostheses.

FIGS. 18A-18E show another exemplary mechanism of attaching leaflets tothe strut frame. FIG. 18A shows a plate attached to a valve assembly toattach the leaflets thereto. FIGS. 18B is a cross-sectional view showingthe leaflets attached between the plate and a strut. FIG. 18C is a topview of the exemplary mechanism. FIG. 18D shows the plate positionedover two leaflets and a strut of the valve assembly. FIG. 18E shows theplate attached to the strut frame.

FIG. 19 shows a method of sewing leaflets around the circumference ofthe strut frame.

FIGS. 20A-20Q show another exemplary mitral valve prosthesis. FIG. 20Ashows the exemplary mitral valve prosthesis in the expandedconfiguration. FIGS. 20B-20C show the expanded prosthesis without theleaflets or skirt for clarity. FIGS. 20D-20G show the expanded anchorassembly. FIG. 20H shows the atrial end of the expanded valveprosthesis. FIG. 20I shows the ventricular end of the expanded valveprosthesis. FIG. 20J is a 2D view of the (unexpanded) anchor assembly.FIG. 20K shows the expanded strut frame. FIG. 20L is a 2D view of the(unexpanded) strut frame. FIG. 20M is a side view of the strut frame.FIG. 20N is a top (atrial) view of the strut frame. FIG. 20O is anotherview of the expanded anchor assembly. FIGS. 20P-20Q are additional viewof the expanded prosthesis without the leaflets or skirt for clarity.

FIG. 21 shows an exemplary leaflet for use with the mitral valveprostheses described herein.

FIG. 22 shows the inflow edges of the leaflets sewn to the strut frame

FIGS. 23A-23C show an exemplary mitral valve prosthesis with a skirtcovering thereon.

FIGS. 24A-24C show an exemplary mitral valve prosthesis with a first setof dimensions.

FIGS. 25A-25C show an exemplary mitral valve prosthesis with a secondset of dimensions.

FIG. 26 shows an exemplary mandrel for shaping a skirt.

FIGS. 27A-27Q show another exemplary method of attaching leaflets to amitral valve prosthesis. FIG. 27A shows a strut frame with a slot in thestrut and a first suture positioned therearound. FIG. 27B shows a secondsuture positioned therearound. FIG. 27C shows a third suture positionedtherearound. FIG. 27D shows the alignment of leaflet protectors. FIG.27E shows the positioning of the leaflets such that they are flush withone another. FIGS. 27F-27H show placement of the leaflet arms throughthe slot in the strut frame. FIG. 27I shows separation of the twoleaflets to attach at additional commissure points. FIG. 27J shows aninflow view of the leaflets after they have been attached at thecommissure attachment points. FIG. 27K shows an outflow view of theleaflets after they have been attached at the commis sure attachmentpoints. FIG. 27L shows the arms of the leaflets wrapped around the strutframe. FIG. 27M shows the leaflet protectors wrapped inside of the strutframe. FIG. 27N shows alignment of the leaflet arms with the strutframe. FIG. 27O shows placement of the plate over the strut frame. FIG.27P shows wrapping of two sutures around the plate. FIG. 27Q showswrapping of the final suture around the plate to attach the leaflets tothe strut frame.

FIG. 28 shows placement of an exemplary valve prosthesis in the nativemitral valve orifice.

FIGS. 29A-29E show a mitral valve prosthesis with a delivery systemattachment mechanism. FIG. 29A shows the expanded valve assembly withpins therein. FIG. 29B shows a close-up of a pin. FIG. 29C shows slotsin the skirt to allow for access to the pins. FIG. 29D shows a 2D(unexpanded) view of the anchor assembly with pins. FIG. 29E shows aclose-up of a pin with dimensions.

FIG. 30 shows another exemplary mitral valve prosthesis with a skirtthereon.

FIGS. 31A-31C show exemplary hooks for a mitral valve prosthesis.

FIG. 32 shows an engagement radius R of hooks on a mitral valveprosthesis.

FIG. 33 shows an exemplary plate for leaflet attachment.

FIG. 34 shows another exemplary plate for leaflet attachment.

FIG. 35 shows an exemplary tubular pre-formed skirt.

FIGS. 36A-36B show an exemplary anchor assembly and strut frame with askirt extending thereover.

FIGS. 37A-37B show additional exemplary mitral valve prostheses withoutthe leaflets or skirt.

DETAILED DESCRIPTION

This disclosure includes replacement heart valves (also referred toherein as prosthetic heart valves), methods of manufacturing replacementheart valves, including subassemblies thereof, and methods of usingreplacement heart valves. This disclosure describes the prostheses inthe context of replacement mitral valves, but it is conceivable that theprostheses herein can be used or modified to be used as otherreplacement heart valves. In some embodiments, the replacement heartvalves are self-orienting replacement mitral valves configured to bedelivered using minimally invasive techniques.

The replacement heart valves described herein include an anchor assemblythat includes an atrial anchor (e.g., configured to be placed on anatrial side of a mitral valve annulus), a ventricular anchor (e.g.,configured to be placed on a ventricular side of a mitral valveannulus), and a central portion positioned axially between the atrialand ventricular anchors. The anchor assembly is adapted to collapse to adelivery or collapsed configuration and expand to an expandedconfiguration. The replacement heart valves also include a strut framesecured to at least one of the central portion, the ventricular anchor,or the atrial anchor for attaching a plurality of replacement leafletsthereto. The strut frame can be configured to deform and collapse as therest of the anchor assembly is collapsed. The struts of the strut frameextend towards and/or past the ventricular anchor.

The replacement heart valves described herein are configured to besecured in the native valve orifice by sandwiching the cardiac orificebetween ventricular and atrial anchors, which are larger in diameterthan the valve orifice, by applying an axial compressive force from theanchors, a radial force from the center portion outward against thecardiac orifice, and/or by using hooks or barbs that extend into thetissue of the orifice.

Further, the replacement heart valves described herein can be deliveredto a cardiac valve orifice, such as the mitral valve, by using minimallyinvasive techniques to access the cardiac valve. In some embodiments,the mitral valve prostheses can be delivered through a transatrialroute, i.e., by making a small incision in the patient's body andpassing the prosthesis through the apex of the heart to, for example,the mitral valve. In other embodiments, the mitral valve prostheses canbe delivered through the transseptal route, i.e., through the venoussystem and into the left atrium via a transseptal puncture. In both thetransatrial and transseptal delivery methods, the distal-most anchor canbe delivered to the ventricle while the proximal-most anchor can bedelivered to the atrium.

FIGS. 1A-1C show an exemplary mitral valve prosthesis 100 in an expandedconfiguration. The portion of the replacement valve prosthesis 100 inFIG. 1 may be referred to as a prosthesis subassembly, which includes ananchor assembly 101 and a strut frame 105, but excludes leaflets and anyskirts that may be incorporated into the final replacement valve. Anchorassembly 101 includes an atrial anchor 102, a ventricular anchor 104,and a central portion 103 therebetween. In this embodiment, atrialanchor 102 is configured and adapted to be disposed on an atrial side ofa mitral valve orifice, and ventricular anchor 104 is configured andadapted to be disposed on a ventricle side of the mitral valve orifice.Further, the central portion 103 can be configured to be situated in themitral valve orifice. In some embodiments, the central portion 103 has adiameter that is substantially the same size as the native mitral valveannulus (i.e., it is not designed to be larger than the annulus).

In some embodiments, the anchor assembly 101 and/or strut frame 105 canbe made of wire, such as a shape memory metal wire (e.g., a nitinol). Inother embodiments, the anchor assembly and/or strut frame can be lasercut from one or more tubes, such as a shape memory metal tube (e.g.,nitinol). For example, the anchor assembly 101 can be laser cut from afirst hypotube while the strut frame 105 can be laser cut from a secondhypotube of smaller diameter. The anchor assembly 101 can be cut, forexample, from a 9-12 mm diameter tube, such as a 10 mm tube, while thestrut frame 105 can be cut, for example, from a 7-9 mm diameter tube,such as an 8 mm tube.

The valve prosthesis 100 can be configured to expand (e.g., self-expand)from a collapsed or constrained (delivery) configuration to an expanded(treatment) configuration. In the expanded configuration shown in FIGS.1A-1B, the atrial anchor 102 and ventricular anchor 104 extend radiallyoutward from central portion 103, and are considered to flare outwardrelative to central portion 103. The atrial anchor 102 and ventricularanchor 104 can also be considered flanged relative to central portion103. The flared configuration of atrial and ventricular anchors 102 and104 relative to central portion 103 is described in the context of aside view of the anchor assembly, as can be best seen in FIG. 1B. Insome embodiments, the flared configuration of the two anchors 102, 104and the central portion 103 define a general hour-glass shape in a sideview of the anchor assembly 101. That is, the anchors 102, 104 can beflared outwards relative to the central portion 103 and then curved orbent to point at least partially back in the axial direction. It shouldbe understood, however, that an hour-glass configuration is not limitedto symmetrical configuration.

The anchor assembly 101 can be configured to expand circumferentiallyand foreshorten axially as the valve prosthesis 100 expands from thecollapsed delivery configuration to the expanded treatmentconfiguration. For example, as shown in FIGS. 1A-1C, the anchor assembly101 can be made of a plurality of cells 111 that are each configured toexpand circumferentially and foreshorten axially upon expansion of theanchor assembly 101. As shown best in FIG. 1C, the cells 111 can each bediamond-shaped. Further, the cells 111 can be interconnected andconfigured such that every diamond apex 117 is connected to anotherdiamond apex 117 except at the atrial or ventricular tips 112, 114 ofthe assembly 101. The anchor assembly 101 can include, for example,three circumferential rows of diamond cells 111. For example, the atrialanchor 102 can comprises one row of diamond-shaped cells 111 extendingcircumferentially, the central portion 103 can comprise one row ofdiamond-shaped cells 111 extending circumferentially, and theventricular anchor 104 can comprise one row of diamond-shaped cellsextending circumferentially 111.

The strut frame 105 can be configured to expand circumferentially, butmaintain the same axial dimension (i.e., be non-foreshortening) as thevalve prosthesis 100 expands from the collapsed delivery configurationto the expanded treatment configuration. By being non-foreshortening,the strut frame 105 can advantageously ensure that less strain is placedon the leaflets during delivery and/or packing. Thus, while the anchorassembly 101 is designed to be foreshortening, the strut frame 105 isdesigned so as to be substantially non-foreshortening. As can be bestseen in FIG. 1B, the strut frame 105 can include a plurality oflongitudinally extending struts 151 and interconnecting v-shaped members153. Further, in some embodiments, and again as shown in FIGS. 1A-1B,the strut frame 105 can have fewer v-shaped members 151 extendingcircumferentially around the diameter thereof than the cells 111 of theanchor assembly 101, such as half the number. Further, the strut frame105 can flare at radially outwards at the atrial end, e.g., to conformto the flare of the atrial anchor 102.

The strut frame 105 and the anchor assembly 101 can be coupled togetherwith coupling members, such as rivets. In some embodiments, and as shownin FIGS. 1A-1B, the atrial tips 129 of the strut frame 105 can becoupled to the atrial tips 112 of the anchor assembly 101. Where thereare fewer v-shaped members 151 in the strut frame 105 than cells 111 inthe anchor assembly 101 (as shown in FIG. 1B), the strut frame 105 canattach to every other atrial tip 112 on the anchor assembly 101.

The radially inner surfaces of strut frame 105 can substantially definethe perimeter of a central opening 106. Replacement leaflets, which arenot shown in FIGS. 1A-1B for clarity, can be secured to the strut frame105 and can be disposed at least partially in the central opening 106.The leaflets are configured to control blood flow therethrough.

In some embodiments, the valve 100 can include hooks 188 or barbs tohelp anchor the assembly in the mitral valve orifice. As shown in FIGS.1A-1C, in one embodiment, the hooks 188 can be on the ventricular mosttips 114 of the ventricular anchor 104.

FIGS. 2A-2E show another exemplary valve prosthesis 200. The valveprosthesis 200 is similar to valve prosthesis 100 and can include manyof the same features as valve prosthesis 100, such as an anchor assembly201 (having atrial anchor 202, a ventricular anchor 204, and a centralportion 203) and a strut frame 205. In contrast to the prosthesis 100,the cells 211 of the anchor 201 are not connected together at everyinterior apex 217. Rather, the middle row of cells 211 can bedisconnected at every other atrial apex 219 at the atrial side. As aresult, there can be fewer atrial tips 212 than ventricular tips 214,and the atrial-most cells can be truncated or v-shaped (i.e., straddlingeach disconnected apex 219 and corresponding diamond-shaped cell). Forexample, there can be 15 atrial tips 212 (and 15 v-shaped cells 211 atthe atrial end) and 30 ventricular tips 214 (and 30 diamond-shaped cellsat the ventricular end). Advantageously, because the atrial tips 212 arelarger/wider than the ventricular tips 214, the atrial tips 212 can bemore flexible to allow the atrial anchor 202 to conform to the tissue.The atrial apexes 219 can be radially aligned with the atrial tips 212and can be positioned approximately mid-way along the diamond-shapedcells at the atrial tips 212 along the central longitudinal axis (asnoted above, the outermost cells can also be considered v-shaped,particularly in 2D, as the inner cell and apex 219 sit within the outerlarger diamond, making it a v-shape).

In some embodiments, each of the atrial apexes 219 can have a rivet holetherein for connection to the atrial tips 229 of the strut frame 205.Further, in some embodiments (and as shown in FIGS. 2A and 2B), theatrial apexes 219 can all be bent slightly radially inwards towards thestrut frame 205 (e.g., further radially inwards than the rest of theanchor assembly 201 so as to meet the strut frame 205). The atrialapexes 219 can be radially aligned with the atrial tips 212 of theatrial anchor 202. Further, the apexes 219, when bent radially inwards,can effectively act as an integrated suspension, holding the centralportion 203 and ventricular anchor 204 radially outwards relative to,and spatially separated from, the strut frame 205. For example, theventricular anchor 204 can be separated from the strut frame 205 by aradial distance of, for example, 1-15 mm, such as 2-11 mm, such asapproximately 3 mm. Further, the central portion 203 can be separatedfrom the strut frame 205 by a radial distance of, for example, 2-3 mm.This separation of the ventricular anchor 204 and/or the central portion203 can advantageously isolate the leaflets from the anchor assembly 201on the ventricular side where the greatest amount of distortion isplaced on the anchor assembly 201.

Further, in this embodiment, the strut frame 205 and anchor assembly 201can be attached at a central point of the atrial anchor 202 (i.e., atapexes 219) rather than at the outer-most or atrial-most tips 212 of theatrial anchor 202. By attaching the inner strut frame 205 to the anchorassembly 201 at a mid-point of the atrial anchor 202 rather than at theatrial tips 212, less torque or torsion is applied to the strut frame205 as the atrial anchor 202 conforms to the tissue, thereby helping toensure that the leaflets maintain their required position.

As shown best in FIGS. 2D and 2E, the strut frame 205 can include aplurality of struts 221 and v-shaped members 223 (so as to besubstantially non-foreshortening as described with respect to strutframe 105). In this embodiment, there are four v-shaped members 223extending axially between each pair of struts 221. The twoventricular-most v-shaped members 223 and the atrial-most v-shapedmember 223 all point in the atrial direction. The last v-shaped member223 points in the ventricular direction. Having a v-shaped member 223that points in the ventricular direction can add to the stiffness of thestrut frame 205. Additionally, having the last v-shaped member 223 pointtowards the atrium reduces the length of the struts and reduces thenumber of vertices that are pointed into the ventricle (to reduce traumato the ventricle). The atrial tips 229 of the strut frame 205 can beformed by the vertex of the “V” shape. Each atrial tip 229 can include arivet hole therein for connection to the anchor assembly 201. Further,the strut frame 205 can include a flare at the atrial end thereof toenable the strut frame to meet the apexes 219 and/or to conform to theflare of the atrial anchor 202. Further, in some embodiments (and asshown in FIG. 2D), the flare at the atrial end of the strut frame 205can include relatively flexible members 209 or zig-zag features therein.The flexible members 209 can be configured to allow the atrial flare toeasily fold up during packing/delivery.

In some embodiments, the number of ventricular cells or ventricular tips214 in valve 200 (or any valve described herein) can be divisible byboth 2 and 3. For example, there can be 18, 24, or 30 ventricular cellsor tips 214. Because the number of ventricular tips 214 is divisible by2, there can be half as many atrial tips 212. Further, by having thenumber of cells divisible by 3, the three attachment points for thethree leaflets (e.g., struts 221 a,b,c) of the strut frame 205 can beeven spaced around the circumference of the central opening 206.Increasing the number of ventricular tips/cells (e.g., from 18 cells to30 cells) in any given design means that the total amount of requiredcircumferential expansion of each individual cell decreases, therebyallowing the longitudinal lengths of the cells to be shorter, decreasingthe overall length of the packed assembly (i.e., during delivery). Insome embodiments, the cells have a length of between 4 and 6 mm and awidth of between 0.2 and 0.4 mm when collapsed, e.g., before expansion.With these dimensions, the packed assembly can be, for example, 30-40mm, such as 32-35 mm. Further, in some embodiments, the cell dimensionsare chosen such that the ratio of width to length yields no more than8-10% sheathing strain when the anchor assembly is retracted into thecatheter for delivery.

FIGS. 3A-3C show another exemplary valve prosthesis 300. Valveprosthesis 300 is similar to valve prosthesis 200 (with anchor assembly301 similar to assembly 201). The strut frame 305, however, includesreduced thickness members 310 in the atrial flare rather than flexiblemembers 209. The reduced thickness members 310 can have a smallerdiameter than the rest of the strut frame 305. The reduced thicknessmembers 310, similar to the flexible members 209, can allow for easierbending at the flare of the strut frame 305, thereby permitting easypacking.

FIGS. 4A-4C show another exemplary valve prosthesis 400. The valve 400is similar to valves 100-300 except that the attachment point betweenthe strut frame 405 and the anchor assembly 401 is at the ventricularend of the strut frame 405. To connect the anchor assembly 401 to theventricular end of the strut frame 405, connecting members 494 extendfrom the anchor assembly 401 (e.g., from the central portion 403 or theventricular anchor 404) to the ventricular tips of the strut frame 405.The connecting members 494 can be integral, for example, with the anchorassembly 401 and then riveted to the strut frame 405. In someembodiments, as shown in FIGS. 4A-4C, the connecting members 414 can bea single longitudinal member. In other embodiments, the connectingmembers 494 can be cells or tips 414 of the ventricular anchor 404 thatare pulled radially inwards (e.g., every other tip 414 of theventricular anchor 404 can be pulled inwards). Further, in someembodiments, an additional layer of cells can be coupled or riveted tothe ventricular anchor 404 to tune the rigidity thereof. As shown inFIGS. 4A-4C, the atrial end of the strut frame 405 can still be flaredat an angle, e.g., to substantially confirm to the flare of the atrialanchor 402 of the anchor assembly 401.

FIGS. 8A-8G show another exemplary valve prosthesis 800 including valveassembly 801 and strut frame 805. Valve prosthesis 800 is similar tovalve prosthesis 200 except that valve prosthesis 800 has a greatercurvature on the flare of the ventricular anchor 804, which can helpimprove retention force in some embodiments. For example, theventricular anchor 804 can flare at an initial angle of 5°-15°, such as10°, relative to a horizontal plane through the central portion 803(and/or 75°-95°, such as 80°, relative to a central axis through theprosthesis 800). Additionally, the anchor assembly 801 includes aplurality of barbs or hooks 888 extending from the ventricular anchor804. Positioning the hooks on the ventricular anchor 804 advantageouslyhelps hold the prosthesis in place, as the ventricular side of themitral valve undergoes the highest pressure. The hooks 888 arepositioned in the valleys between the ventricular tips 814. Further,each hook 888, when the anchor assembly 801 is in the expandedconfiguration, is curved backwards to point at least partially in theatrial direction.

FIGS. 20A-20Q show another exemplary valve prosthesis 2000 including avalve assembly 2001 and a strut frame 2005. Prosthesis 2000 is similarto valve prosthesis 800 except that that the tips 2014 of theventricular anchor 2004, after flaring radially outwards at the angle of5-15° relative to the horizontal plane 2020, can curve away from thehorizontal axis 2020 to point substantially in the axial (ventricular)direction, such as at an angle of 60-70°, such as 67° relative to thehorizontal plane 2020. The curvatures of the two portions can be between2 mm and 8 mm, respectively. Similarly, the atrial anchor 2002 canextend at an initial angle of 20°-30°, such as approximately 26°,relative to the horizontal plane 2020 through the central portion 2003.The tips 2012 of the atrial cells can then curve away from the axis 2020to point more in the axial (atrial) direction, such as at an angle of60-70°, such as 67° relative to the horizontal plane 2020. Thecurvatures of the two portions can be between 2 mm and 8 mm,respectively. Further, the atrial apexes 2019 with the rivet holestherein can extend at an angle of approximately 50-70°, such as 60°relative to the axis 2020, to meet and affix to the strut frame 2050.Similarly, the atrial tips 2029 of the strut frame 2005 can flare out atapproximately 70°-80° relative to the horizontal axis 2020 so as tosubstantially conform to the flare of the atrial apexes 2019. There canbe 30 atrial cells along a single circumference and only 15 ventricularcells.

Further, as is best shown in FIGS. 20K-20N, the strut frame 2005 isdifferent from the strut frame 805 in that the strut frame 2205 does notinclude flexible members (e.g., zig-zag features) in the flare at theatrial end of the strut frame 2005. Rather, the connecting member on theanchoring structure can be made more compliant. Like strut frame 205,the strut frame 2005 includes a plurality of struts 2021 and v-shapedmember 2023 so as to be non-foreshortening. In strut frame 2005,however, there are five v-shaped members 2023 extending between eachpair of struts 2021 rather than four. The extra v-shaped member 2023 ispositioned proximate to the atrial-most v-shaped member 2023 and extendsfrom the struts 2023 in the atrial direction. The extra v-shaped membercan advantageously add circumferential strength to the strut frame 2005.The strut frame 2005 can further include one or more slots 2733 in thestruts 2021 to allow for attachment of leaflets, as described below.

The anchor assembly 2001 also includes barbs or hooks 2088 that, similarto hooks 888, are positioned between the ventricular tips 2014 in thevalleys and are curved backwards towards the atrial end. Further, insome embodiments, and as shown at FIGS. 20O-20Q, the hooks 2088 can bepositioned between every ventricular cell 2011 (e.g., in the valleys)except those valleys closest to the commis sure attachment points. Atthose points, one or more (such as one, two, or three) of the hooks 2088can be removed so as to prevent interference with the commissures and/orleaflets when the prosthesis is in the collapsed configuration.

In some embodiments, such as for the anchor assembly 2000, the atrialanchor 2002 can have a larger diameter than the ventricular anchor 2004.Having a larger atrial anchor 2002 than a ventricular anchor 2004 allowsthe anchors 2002, 2004 to grip tissue while preventing the ventricularanchor 2004 from impeding flow to the aortic valve. That is, as shown inFIG. 28, if the ventricular anchor is too large, then the LeftVentricular Outflow Tract (LVOT) 2828 may be obstructed and restrictflow through the adjacent aortic valve 2829. In some embodiments, forexample, the atrial anchor 2002 can have a diameter that is 3-10% largerthan the diameter of the ventricular anchor 2004. The ventricular anchor2004 can thus be less than 55 mm, such as less than or equal to 54 mm,such as less than or equal to 52 mm.

As described above, the number of ventricular cells or ventricular tipsin any of the valves described herein can be divisible by both 2 and 3.For example, as shown in FIG. 37A, there can be 30 ventricular tips and15 atrial tips. As another example, there can be 24 ventricular tips and12 atrial tips, as shown in FIG. 37B.

In some embodiments, the prostheses described herein can be made in aplurality of different sizes so as to fit within a range of native valveorifice sizes. For example, referring to FIGS. 24A-24C, in someembodiments, a valve prosthesis 2400 can have an atrial anchor 2402 withan outer diameter of 54 mm, a ventricular anchor 2404 with an outerdiameter of 52 mm, and a central portion 2403 with an outer diameter of36 mm. Further, the strut frame 2405 can have an inner diameter of 27mm-30 mm, such as approximately 29 mm. A total height of the prosthesis2400 can be, for example, 22-28 mm, such as 26 mm. In contrast, thevalve prosthesis 2500 of FIGS. 25A-25C can have a larger diameter to fitwithin a larger native valve orifice. For example, the atrial anchor2502 can have an outer diameter of 59 mm, the ventricular anchor canhave an outer diameter of 54 mm, and the central portion 2503 can havean outer diameter of 40 mm. The strut frame 2505, like the strut frame2405, can have an inner diameter of 27 mm-30 mm, such as 29 mm. Tocompensate for the increased diameter of the valve assembly 2501relative to the strut frame 2505, the disconnected atrial apexes 2519can be pulled further radially inwards (for example, the disconnectedatrial apexes 2519 can be pulled downwards in an s-shape to reachfurther inwards). A total length of the expanded valve 2500 can be 28-29mm. Further, in order to maintain low packing strain, the sheathed orpacked length of the valve 2500 can be longer than the packed length ofthe valve 2400. For example, the packed length of valve 2400 can be 32mm-35 mm while the packed length of valve 2500 can be 34 mm-37 mm.

Anchor assemblies 101-401, 801, 2001, 2401, and 2501 all foreshortenupon expansion (due to their cellular design). For example, the anchorassemblies can foreshorten by 20%-30%. In contrast, the correspondingstrut frames 105-405, 805, 2005, 2405, and 2505 maintain substantiallythe same axial length.

In some embodiments, the prosthesis can be designed such that the entireprosthesis does not foreshorten during expansion. Having the prosthesisnot foreshorten advantageously allows the packed length to be muchshorter, such as less than 35 mm, such than 30 mm, or less than 25 mm.

For example, FIGS. 5A-5C show an anchor assembly 501 that includes aplurality of struts 505 and circumferential v-shaped connectors 507 thatdo not substantially foreshorten upon expansion. The anchor assembly 501forms a primarily hour-glass shape in the expanded configuration.Further, the atrial end includes flexible members 519 (e.g., zig-zagmembers) to aid in conforming to the native orifice.

FIGS. 6A-6C show another exemplary nonforeshortening anchor assembly 601with a plurality of struts 605 and circumferential v-shaped connectors607. In this embodiment, the ventricular anchor 604 is curled inwards atthe tips to minimize interaction with the native ventricular anatomy.

FIGS. 9A-9D show another exemplary nonforeshortening anchor assembly 901with a plurality of struts 905 and circumferential v-shaped connectors907. In this embodiment, there are 5 v-shaped connectors 907 extendingbetween each set of struts 905. The ventricular ends of the ventricularanchor 904, like ventricular anchor 604, curl in at the tips to minimizeinteraction with the native anatomy. Further, the struts 905 eachinclude a flexible portion 929 (e.g., zig-zag or serpentine section)that extends from the atrial tips to the central portion 903. Theflexible portions 929 aid in conforming the atrial anchor 902 to thenative orifice. In this embodiment, the strut frame (which can be anystrut frame described herein) can be configured to attached mid-wayalong the atrial anchor 902, such as rivet location 939. Advantageously,by attaching the strut frame at the atrial anchor (i.e., rather than theventricular anchor), the strut frame can be less prone to distortionthat can occur when the ventricular anchor is expanded during delivery.

Various hook or barb mechanisms can be used with any of the valvesdescribed herein. For example, the barb or hook can be riveted to theanchor assembly, can be laser cut from the assembly, and/can be formedas part of a v-shaped feature of the anchor assembly. The hook or barbmechanisms can be designed such that they point radially outwards duringdeployment (i.e., not into the tissue) and do not engage with tissueuntil fully released, thereby preventing interference with thedeployment. This can be achieved, for example, by using a hook havingthe proper radius of curvature to thickness ratio.

In some embodiments, the hooks can be on the ventricular most tips ofthe ventricular anchor, as shown in FIGS. 1A-1C. In other embodiments,the hooks can be in the valleys (i.e., between petals or tips, as shownin FIGS. 8A-8G and 20A-N). For example, the hooks can be placed invalleys on the ventricular anchor (e.g., from an apex of an interiordiamond-shaped cell). When positioned between valleys on the ventricularanchor, the hooks can curve around and point in the atrial direction atan angle of 40°-90°, e.g., 50°-80°, e.g., 57-67°, such as about 62°relative to a horizontal axis of the device (or up to 50°, e.g.,10°-40°, such as 23°-33°, such as about 28° relative to a centrallongitudinal axis of the device). This angle can advantageously allowthe hooks to point in the atrial direction to dig into tissue.

Referring to FIGS. 31A-31C, each hook 3188 on implant 3100 (which can beany implant described herein) can arc along an angle a of between99°-119°, such as 104°-114°, such as approximately 109. Further, eachhook 3188 can have a ratio of radius of curvature RC to thickness T of4:1 or greater. Having a ratio of radius of curvature RC to thickness Tof 4:1 or greater ensures that the hooks 3188 can bend from their curvedconfiguration to lay flat during collapse (e.g., for delivery). In someembodiments, a radio of width W to thickness T of each hook 3188 can bebetween 0.3:1 and 1:1, such as between 0.4:1 and 0.6:1. Having a ratiowithin this range advantageously ensures that the hooks 3188 don't twistor bend sideways when collapsed or laid flat (e.g., for delivery of theimplant).

In some embodiments, the ratio of radius of curvature RC to thickness Tis between 4:1 and 10:1, such as between 5:1 and 9:1. The radius ofcurvature RC can, for example, be less than 4 mm, such as between 2 mmand 4 mm, such as between 2.5 mm and 3.5 mm, such as approximately 3 mm.The thickness T of the hook can be less than 1.6 mm, such as between0.25 mm and 1 mm, such as between 0.3 mm and 0.5 mm, such as between0.39 mm and 0.45 mm, such as approximately 0.42 mm. The width W of thehook can be between 0.1 mm and 0.4 mm, such as between 0.2 mm and 0.3mm, such as approximately 0.22 mm.

In one exemplary embodiment, the radius of curvature of the hook is 3mm, the thickness of the hook is 0.42 mm, and the width of the hook is0.22 mm. The ratio of radius of curvature to thickness is thereforeapproximately 7.1:1, and the ratio of width to thickness is therefore0.5:1.

Referring to FIG. 32, in some embodiments, the hooks 3288 on an implant3200 (which can be any implant described herein) can be configured toengage tissue (e.g., extend within tissue of the native mitral valveannulus) at a radius R of between 2-20 mm, such as 3-10 mm, such asapproximately 3.4 mm. Having a radius of engagement within this rangeadvantageously ensures that the hooks 3288 can engage with tissue evenwhen the native valve is not circular while ensuring that the hooks 3288do not interfere with the adjacent aortic valve. For example, thediameter D1 of the implant 3200 at the connection of each hook 3288(e.g., radially inner most point of the hooks) can be 30-50 mm, such as40-48 mm, such as approximately 45 mm. The diameter D2 of the implant3200 at the tip of each hook 3288 (e.g., the radially outer most pointof the hook) can be 40-60 mm, such as 45-5 5mm, such as 52 mm.

In some embodiments, the hooks can be riveted to the anchor assembly. Inother embodiments (as shown in FIGS. 7A-7B), the hooks can be tabs thatare flared out from the anchor assembly.

In some embodiments, as shown in FIGS. 9A-9D, a portion of the anchorassembly 901 can include a portion that is pointed radially outwards toact as a hook or barb in the tissue. For example, one set of thev-shaped circumferential members 907 can be bent to point outwards. Thebent v-shaped members can be positioned, for example, on the innerdiameter of the ventricular anchor 904 pointing towards the atrium.

Any of the valve prostheses described herein can include a fabric coverand/or skirt on one or more portions of the device. For example,referring to FIGS. 16A-16D (valve is shown in a holder for clarity), acovering or skirt 1616 can be sewn along the inner diameter of theatrial anchor 1616 and the flare of the strut frame 1605 and down theentire inner diameter of the strut frame 1605. This skirt 1616 can thusprovide a smooth entrance for blood into the leaflets 1622. Further, theskirt 1616 can extend along the entire outer diameter of the anchoringassembly and then around the tips of the ventricular anchor 1604. Insome embodiments, the skirt 1616 can be a single piece while in otherembodiments, the skirt 1616 can be made of a plurality of pieces.

In some embodiments, as shown in FIG. 20A, the skirt 2016 can leave theventricular tips of the ventricular anchor 2004 uncovered. In otherembodiments, as shown in FIG. 30, the skirt 3006 can be wrapped fullyaround the ventricular tips of the ventricular anchor 3004.

In some embodiments, the skirt, or a portion of the skirt, can be knitin a three-dimensional shape, e.g., an hour glass shape, to helpmaintain a consistent seal of the skirt against the prosthesis and tohelp pack the skirt-covered prosthesis during delivery. For example, asshown in FIGS. 23A-23C, the skirt 2316 can be cut in an hour-glass shapeand configured to cover all of the exposed sections of the valve on theatrial side (leaving only the ventricular side of the ventricular anchorand the outer diameter of the strut frame uncovered).

Further, in some embodiments, and as shown in FIGS. 23A-23C, the skirt2316 can be cut in a saw-tooth pattern on the ventricular side to mimicthe pattern of cells that extend to the outermost diameter of theventricular anchor. Cutting the skirt in such a manner can help pack theventricular anchor into the delivery device by reducing the packeddiameter of the ventricular anchor.

Referring to FIG. 35, a skirt 3516 can be pre-formed as a tubularthree-dimensional structure. The skirt 3516 can have a wide section 3535configured to form around the outside or external surface of the anchorassembly and a narrow section 3553 configured to form against the insideor internal surface of the strut frame. The central section 3552 betweenthe wide section 3535 and the narrow section 3552 can have a tapereddiameter. The skirt 3515 can be wrapped around the anchor assembly andstrut frame such that the first end 3554 is positioned at the tips ofthe ventricular anchor, the wide portion 3535 conforms to the outside ofthe anchor assembly, the tapered central section 3552 extends betweenthe atrial anchor and the atrial end of the strut frame, and the narrowsection 3553 is folded or everted into the strut frame so as to conformto the interior surface of the strut frame (with the second end 3555positioned at the ventricular end of the strut frame). As shown, thefirst end 3554 can have a saw-tooth pattern so as to mimic the points ofthe cells forming the ventricular anchor and/or the second end 3555 canhave a saw-tooth pattern so as to mimic the apexes at the ventricularend of the strut frame. In some embodiments, the skirt 3516 can havepre-formed cuts (e.g., laser cuts) to provide access to hooks,commissure attachment mechanisms, delivery system attachment mechanisms,or other elements of the underlying frame.

FIG. 36 shows a skirt 3616 that is formed and wrapped around the valvesimilar to as described with respect to skirt 3516. In this embodiment,however, the first and second ends 3654, 3655 are not in a saw-toothconfiguration. Rather, the end 3654 is straight and ends at the tips ofthe ventricular anchor 3604 while the end 3655 is straight and iswrapped around the tips of the ventricular end of the strut frame 3605.It should be understood that one or both of the ends 3655, 3654 could besaw-tooth, one or both could be wrapped, and/or or one or both could endat the tips. Further, the skirt 3655 can be sewn to the frame (e.g.,with polyethylene sutures) at the edges thereof.

Referring to FIG. 26, if a skirt is knit or otherwise formed in athree-dimensional shape, an inner mandrel 2626 can be used (i.e., theskirt can be knit or formed over the mandrel). After the skirt has beenformed around the mandrel 2626, the mandrel 2626 can dissolve orotherwise break apart to leave the formed skirt. In some embodiments, awoven fabric, such as a polyester weave, can be used to form the skirtover the mandrel 2626. In other embodiments, a polyurethane layer can bepainted or otherwise applied over the mandrel 2626. The polyurethane canadvantageously create fewer wrinkles than a woven fabric. If apolyurethane layer is used, a flap of material may be added in order tocreate some give in the skirt as the valve is packed and/or unpacked.Further, in some embodiments, one or more polyurethane layers can beadded after the skirt is sewn onto the frame (e.g., to fill in any holescaused by sewing the skirt to the frame the material).

The skirts described herein can be made of polyethylene terephalate(PET), polyester, or PET with a polyurethane dispersion.

The skirt can advantageously help block blood flow from one side of thevalve over the other. The skirt can also help prevent the anatomy fromhaving an adverse interaction with the frame itself.

In some embodiments, a coupler can be used to connect the strut frame tothe anchor assembly. Rivets herein are an example of a coupler. Thelocations where components are secured to one another may be referred toas a coupling herein. Coupling also refers to the two components thatare secured together. Riveting as used herein is an example of a methodthat plastically deforms a coupler to secure two or more componentstogether at a coupling. Coupling and rivets are described further inU.S. patent application Ser. No. 14/677,334, filed Apr. 2, 2015, titled“REPLACEMENT CARDIAC VALVES AND METHODS OF USE AND MANUFACTURE,” theentire contents of which are incorporated by reference herein.

In some embodiments, the valve prostheses have been shown withoutleaflets for clarity. It is to be understood that each of theembodiments described herein can include replacement leaflets 1022 a,b,cattached thereto, as shown in FIG. 10. An exemplary leaflet 2122 isshown in FIG. 21. The leaflet can include an outflow (or free) edge 2191configured to float within the strut frame, an inflow edge 2193configured to be sewn to the strut frame, and two arms 2195 a,b. Aplurality of sewing holes 2197 can provide for sewing of the leaflet2122 to the strut frame. Thus, as shown in FIG. 19, the outercircumference of the leaflets at the inflow edges can be sewn to thestrut frame and/or to the skirt covering the skirt frame. That is, whilethe commissures or edges of the leaflets can be attached as describedabove, the inflow edges of the leaflets can be sewn all around thecircumference of the strut frame.

Further, the leaflets can be attached to any of the valve prosthesisdesigns in a variety of different ways.

For example, referring to FIGS. 11A-11F, two commissure plates 1010 a,bcan be used to sandwich the arms of the leaflets 1022 a,b therebetween.The leaflets 1022 a,b can then be sewn together (and to the plates 1010a,b) with one or more suture 1011 through holes 1013 a,bc. After beingsewn together, the joined leaflets and commis sure plates can then beattached to the strut frame 1105 through, for example, a series of holes1113 a,b,c in one of the struts 1121 using a suture 1017 (which can bethe same or different than suture 1011). The commissure plates 1010 a,bcan be made, for example, of stainless steel or plastic. Advantageously,the commissure plates 1010 a,b can apply compression to the leaflets1022 a,b and distribute strains along the length of the commis sureplates, thereby reducing tearing or strain propagation through thetissue.

Another exemplary mechanism for leaflet attachment is shown in FIG. 12.Here, rather than using two commissure plates, a single u-shaped plate1110 with a set of holes on either side can be used. In contrast to thecommissure plates 1010 a,b, the plate 1110 can place a fixed amount ofcompression on the leaflets that are sandwiched therebetween.

Additional exemplary mechanisms for leaflet attachment are shown inFIGS. 14 and 15A-15C. In the version of FIG. 14, the arms of twoleaflets 1022 a,b are pulled through a slot 1333 that is part of a strut1321 of the strut frame. A secondary member 1313 having a width greaterthan the width of the slot 1313 is placed against both arms leaflets,and then the arms of the leaflets 1022 a,b are wrapped around thesecondary member 11313 and attached together with a suture 1311 orstaple. The secondary member 1313 can be coupled to the strut frame, forexample with a rivet. In a similar embodiment, shown in FIGS. 15A-15C,the leaflets 1022 a,b can be passed through a slot in a secondary member1515 and then wrapped around a strut 1521 of the strut frame.Advantageously, the mechanisms of FIGS. 14 and 15A-C evenly distributehigh stress areas of leaflet along the length of strut 1312 or rivetedslot 1321. The load distribution along the given length of these membersdecrease stresses in comparison to attachment methods where many stressconcentrations are created i.e. sutures.

Another exemplary mechanism for leaflet attachment is shown in FIGS.18A-18E. In this embodiment, a plate 1818 including a plurality of holes1819 can be positioned on the outside of the strut frame 1805. Further,the strut frame 1805 can include a slot 1833 therethrough. The arms ofthe leaflets 1822 a,b can then be extended through the slot 1833 andflattened against the outer surface of the strut frame 1805. The plate1818 can be placed against the arms of the leaflets 1822 a,b and thensutured to the arms of the leaflets, e.g., through the holes 1819. Thearms of the leaflets 1822 a,b can thus be sandwiched between the plate1818 and the strut frame 1805. In some embodiments, the suture isattached to a skirt or fabric layer on the strut frame 1805 rather thandirectly to the strut frame.

Another exemplary mechanism for leaflet attachment is shown in FIGS.27A-27R. In this embodiment, a plate 2727 with a plurality of channels2773 (or open slots or indents) in the sides thereof can be positionedon the outside of the strut frame 2705. The channels 2773 can extenddiagonally towards the center of the plate 2727. There can be two ormore channels 2773, such as between 6 and 12 channels 2773, such as tenchannels 2773. Further, the frame 2705 can include three slots 2733therethrough (one for each attachment point) that are positionedequidistant from one another around the circumference of the strut frame2705. The slots 2733 can be positioned within a strut 2721 at theventricular end. To attach the leaflets 2722 a,b to the frame 2705, afirst suture 2772 a can first be threaded between the frame 2705 andskirt 2716 fabric and around the slot 2733. The first suture 2772 a canthen be slid distally towards the ventricular tips 2777 of the strutframe 2705 (FIG. 27A). At FIG. 27B, a second suture 2772 b is threadedsimilarly to the first suture 2772 a. At FIG. 27C, a third suture 2772 cis pierced through the fabric just distal to the slot 2733 from theoutside and back, wrapping the third suture 2772 c around the frame2705. At FIG. 27D, two leaflets 2722 a,b can be aligned, and leafletprotectors 2773 (e.g., made of a lubricious fabric, such as a polyesterweave) can be placed along the outward-facing side of each arm 2795 a,bof the leaflets 1022 a,b. At FIG. 27E, the arms 2795 a,b and leafletprotectors 2773 a,b of the leaflets 1022 a,b can remain flush. As shownin FIGS. 27G-I, the leaflet arms 2795 a,b can be slid through the slot2733. As shown in FIG. 27F, the arms 2795 a,b can be positioned atapproximately a 90 degree angle relative to the slot 2733. As shown atFIG. 27G, each arm 2795 a,b can be slid through the slot 2733 until thebeginning of the bump 2778 on the arm 2795 a,b is flush with the insideof the slot 2733 (to do so, the inflow edges 2793 can be folded inwardtowards one another and the central axis. At FIG. 27H, the arms 2795 a,bcan be at approximately 90 degrees relative to the slot 2733 after beingpulled therethrough. At FIG. 27I, the two leaflets 2722 a,b can beseparated, and, at FIGS. 27J and 27K, the process can be repeated foreach of the other slots and attachment points (e.g., two additionalslots/leaflet attachment points). As shown at FIGS. 27L and 27M, theleaflet arms 2795 a,b can be folded away from one another, and theleaflet protectors 2773 a,b can be folded away from one another. Asshown at FIG. 27N, the edges of each arm 2795 a,b can be placedhorizontal to the outflow plane and the side/vertical edges can beparallel with the strut members 2721. At FIG. 27O, the plate 2727 can beplaced onto the leaflet arms and aligned with the slot 2733. Thevertical edges 2761 of the retaining plate 2727 can be aligned parallelwith the vertical strut members 2721. The top 2762 of the retainingplate 2727 can be aligned with the outflow tips 2777 of the strut frame2705. The center of the retaining plate 2727 can be aligned with thecenter of the slot 2733. At FIG. 27P, the first suture 2772 a can bewound around the top set of indents 2773 a,b in the plate 2727 and thethird suture 2772 c can be wound around the bottom set of indents 2773i,j. At FIG. 27Q, the second suture 2772 b can be woven around the plate2727 into the remaining indents 2773 c-h in a crisscross pattern (dottedlines represent suture on the backside of the plate 2727). The processcan be repeated at each of the commis sure attachment points. Thesutures can advantageously help prevent translation of the plate 2727relative to the slot 2733 and frame 2705. Further, the plate 2727 andslot 2733 can advantageously securely attach the leaflets 2722 to theframe 2705 without damaging the frame 2705, leaflets 2722 a,b, and/orskirt 2716.

FIGS. 33-34 show additional plate embodiments that are similar to plate2727. Referring to FIG. 33A, the plate 3327 is similar to plate 2727except that the indents 3373 are longer and have a different angle thatthe indents 2773 of plate 2727. Thus, the top sent of indents 3373 a, bin the plate 3427 are at an angle of approximately 90 degrees relativeto the longitudinal axis 3333 of the device. Indents 3373 c,d are angledupwards at 30-60 degrees, such as approximately 45 degrees relative tothe longitudinal axis 3333. Indents 3373 e,f are angled downwards at30-60 degrees, such as approximately 45 degrees, relative to thelongitudinal axis 3333. Indents 3373 g,h are angled upwards again at30-60 degrees, such as approximately 45 degrees, relative to thelongitudinal axis 3333, and intents 3373 i are at an angle ofapproximately 90 degrees relative to the longitudinal axis 3333.Further, each of the intents 3373 c-h extends 15-30%, such as 20-25% ofthe width of the plate 3327.

Referring to FIG. 34A, the plate 3427 is similar to plate 2727 exceptthat the indents 3473 are all at an angle of substantially 90 degreesrelative to the longitudinal axis 3433. Further, the inner edge of eachof the indents 3473 c-h has a substantially circular shape. The indents3473 c-h each extend approximately 10%-25%, such as 15%-20% of the widthof the plate 3427.

In some embodiments, referring to FIG. 22, once the arms of the leaflets2222 are attached to the strut frame 2205, the inflow edges can be sewnto the strut frame 2205. An exemplary sewing line 2525 (close to therivets 2527 at the atrial end of the strut frame 2205) is shown in FIG.22.

In some embodiments, a valve prosthesis as described herein can includea delivery system attachment mechanism. For example, as shown in FIGS.2A-2B, the atrial tips 212 can each have a pin 215 extending therefrom(e.g., in the ventricular direction) around which tethers from adelivery system can be wound.

Another delivery system attachment mechanism is shown in FIGS. 29A-29E.The atrial tips 2912 each have a pin 2915 extending therefrom (e.g., inthe ventricular direction). Each pin can be, for example, 0.030 incheslong and approximately 0.012 inches thick. Further, as shown in FIG.29E, the skirt 2916 can have slots 2985 therein that are aligned withthe pins 2915. The slots 2985 can allow for the passage of the tetherstherethrough (i.e., to provide access to the pins 2195).

An exemplary method of delivering a valve prosthesis 1700 (which can beany of the valves prostheses described herein) after attachment to thetethers of the delivery system is shown in FIGS. 17A-17J. At FIGS. 17Aand 17B, the valve is packed inside of a sheath such that the tips ofthe ventricular anchor 1704 point towards the ventricular end (i.e.,away from the central portion 1703) and the tips of the atrial anchor1702 point towards the atrial end (i.e., away from the central portion1703). The valve 1700 can be delivered, e.g., transseptally, to thenative annulus in this packed positioned. At FIGS. 17C-E, theventricular anchor 1704 is partially deployed, i.e., to allow theventricular anchor 1704 to begin to flare outwards. In this embodiments,barbs on the device point radially outwards rather than towards theatrium during the initial deployment steps. At FIGS. 17F and G, thevalve is pulled 1-3 cm towards the atrium to seat the ventricular anchor1704 on the ventricular side of the annulus. At FIG. 17H, theventricular anchor 1704 is fully deployed, allowing the barbs to extendinto the tissue. At this point, the strut frame 1705 (holding leaflets)is also fully exposed. At FIG. 17I, the atrial anchor 1702 is partiallyreleased to allow the anchor 1702 to drop against the wall of theatrium. At FIG. 17J, the atrial anchor 1702 is fully released, and thevalve 1700 is seated in place.

The valve prostheses described herein can advantageously pack to a verylow packing length, such as less than 4 cm, less than 3.8 cm, less than3.6 cm, less than 3.2 cm, or less than 3.0 cm for delivery with a 32French catheter. This low axial packing length advantageously allows theprostheses to be delivered transseptally, e.g., be easily maneuveredaround the bend through the septum.

Further, the cells and/or v-shaped patterns of the valve prosthesesdescribed herein can be specifically designed so as to ensure that theventricular side doesn't flare out when delivered. For example, bymaking the atrial anchor flexible (e.g., with flexible members), theventricular anchor is less likely to hook around when delivered. Asanother example, the radius of the valve (the anchor or the strut frame)can be tuned and/or the valve can be made more flexible in specificareas (of the anchor or the strut frame) so as to ensure that the valveis less prone to hooking/flaring out when delivered. That is, referringto FIGS. 13A and 13B, in one embodiment, a change in the radius ofcurvature in region 1401 will yield a change in the deployment angle øof the ventricular anchor in region 1402. Decreasing the curvature inregion 1401 will make the frame less prone to wrapping around thecatheter tip when the ventricular anchor is exposed from the catheter.In another embodiment, by making region 1401 flexible, but leaving theremaining portions of the ventricular and atrial anchors relativelystiff, the deployment angle ø in region 1402 is less prone to wrappingaround the catheter tip when the ventricular anchor is exposed from thecatheter tip.

The valve prostheses described herein can advantageously avoidinterference with blood flow through the valve. For example, theskirting and shape of the nitinol on the inflow (or atrial) portion ofthe valve can be contoured to provide smooth approach to the valveorifice. This helps decrease the risk of any turbulent flow or pocketsof stagnant blood. As another example, the attachment point between theinner strut and the outer frame can be adjusted longitudinally to changethe relative obstruction of the inner strut with blood flow and theventricular sub-valvular apparatus. As yet another example, the skirtingcan be selectively applied to areas only in which there is a risk ofblood escaping between the prosthesis and the anatomy. By allowing somecells to be open, particularly on the ventricular anchoring member,there is less impedance to flow.

Any of the valve features or structural details of any device embodimentdescribed herein can be incorporated or combined with any of the otherembodiments herein. For example, the central members described hereinare not limited in use with the anchor assemblies and strut frames inthe specific embodiment, but can be replaced with any of the featuresdescribed in any other embodiment.

In use, when the devices described herein can be used as mitral valvereplacements. In some embodiments, when the replacement heart valve hasbeen delivered near the mitral valve, the ventricular anchor can bedeployed first in a cardiac chamber, such as the ventricle, andretracted to a seated position against the valve orifice, such as themitral valve orifice. Then the center portion and atrial anchor portionmay be deployed in another cardiac chamber, such as the atrium, whereinthe expansion and reconfiguration of the atrial anchor and the centralportion sandwiches the valve orifice securely between the anchors thathave been deployed on either side of the annulus. Other exemplaryaspects of the methods of delivery described in U.S. Pat. No. 8,870,948,issued Oct. 28, 2014, in International Patent Application No.PCT/US2016/032546, filed May 13, 2016, titled “CARDIAC VALVE DELIVERYDEVICES AND SYSTEMS,” and in U.S. Provisional Patent Application Nos.62/424,021 and 62/424,051, both filed Nov. 18, 2016 and titled “CARDIACVALVE DELIVERY DEVICES AND SYSTEMS” all of which are incorporated byreference in their entireties.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and variations such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1. A prosthetic mitral valve comprising: a valve support assemblycomprising a ventricular anchor, a central portion, and an atrialanchor, the valve support assembly configured to self-expand from acollapsed configuration to an expanded configuration; a plurality ofleaflets secured to the valve support assembly; and a plurality ofretention hooks attached to the ventricular anchor, wherein each of theretention hooks curves radially outwards to point in an atrial directionwhen the valve support assembly is in the expanded configuration, eachretention hook having a ratio of radius of curvature to thickness of 4:1or greater.
 2. The prosthetic mitral valve of claim 1, wherein the ratiois between 4:1 and 8:1.
 3. The prosthetic mitral valve of claim 1,wherein each of the plurality of retention hooks is configured to pointat an angle of 10-40 degrees relative to a central longitudinal axis ofthe prosthetic mitral valve.
 4. The prosthetic mitral valve of claim 3,wherein the angle is approximately 28°.
 5. The prosthetic mitral valveof claim 1, wherein a radius of curvature of each of the plurality ofretention hooks is less than 4 mm.
 6. The prosthetic mitral valve ofclaim 1, wherein a radius of curvature of each of the plurality ofretention hooks is between 2 mm-4 mm.
 7. The prosthetic mitral valve ofclaim 1, wherein a thickness of each of the plurality of retention hooksis less than 1.6 mm.
 8. The prosthetic mitral valve of claim 1, whereina thickness of each retention hooks is between 0.25 mm and 1 mm.
 9. Theprosthetic mitral valve of claim 1, wherein a ratio of width tothickness of each retention hook is between 0.3:1 and 1:1.
 10. Theprosthetic mitral valve of claim 1, wherein each hook is configured toengage approximately 3-10 mm of mitral valve tissue when the valvesupport assembly is in the expanded configuration.
 11. The prostheticmitral valve of claim 1, wherein the plurality of retention hooks areintegral with the valve support assembly.
 12. The prosthetic mitralvalve of claim 1, wherein the valve support assembly includes an anchorassembly comprising the ventricular and atrial anchors and the centralportion and an annular strut frame positioned radially within the anchorassembly.
 13. The prosthetic mitral valve of claim 12, wherein theplurality of retention hooks are attached to the anchor assembly. 14.The prosthetic mitral valve of claim 1, wherein the central portion isconfigured to align with a native valve orifice, and wherein theventricular anchor and the atrial anchors are configured to compressnative cardiac tissue therebetween.
 15. The prosthetic mitral valve ofclaim 1, wherein the valve support assembly comprises a plurality ofdiamond-shaped cells, wherein each of the retention hooks extends froman apex of an interior diamond-shaped cell.
 16. The prosthetic mitralvalve of claim 15, wherein a retention hook extends from each apex in acircumferential line around the prosthetic mitral valve except aposition closest to a leaflet attachment point.
 17. A prosthetic mitralvalve comprising: a valve support assembly comprising a ventricularanchor, a central portion, and an atrial anchor; a plurality of leafletssecured to the valve support assembly; and a plurality of retentionhooks attached to the ventricular anchor, wherein each of the retentionhooks curves radially outwards to point in an atrial direction, eachretention hook having a ratio of radius of curvature to thickness ofgreater than 4:1 and points at an angle of 10°-40° relative to a centrallongitudinal axis of the prosthetic mitral valve.
 18. The prostheticmitral valve of claim 17, wherein a ratio of width to thickness of eachretention hook is between 0.3:1 and 1:1.
 19. The prosthetic mitral valveof claim 17, wherein each hook is configured to engage approximately3-10 mm of mitral valve tissue when the valve support assembly is in theexpanded configuration.
 20. The prosthetic mitral valve of claim 17,wherein a radius of curvature of each of the plurality of retentionhooks is less than 4 mm.